OrganaBio, LLC (“OrganaBio”) is expanding its product portfolio with the addition of current Good Manufacturing Practices (cGMP)- and current Good Tissue Practices (cGTP)-compliant perinatal umbilical cord blood and leukopak products. Obtained from fully consented donors, under IRB-approved protocols, with comprehensive testing and supporting documentation to meet the regulatory requirements of the US FDA and other regulatory agencies, OrganaBio’s cGMP compliant products further deliver on OrganaBio’s commitment to providing high quality critical starting materials to cell therapy and cancer immunotherapy developers. Marketed under the HematoPAC™-GMP and LeukoPAC™-GMP brands, these products are a source of hematopoietic stem cells (HSCs) and lymphoid- and myeloid-derived immune cells, including T, NK, T-reg, gamma delta T cells, macrophages, and B cells, which are critical raw materials for allogeneic regenerative medicine, cell therapy, and immunotherapy development and manufacturing.
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OrganaBio’s Research Use Only (RUO) leukopaks (LeukoPAC™) are currently available as fresh or cryopreserved full- or quarter-sized bags. cGMP leukopaks (LeukoPAC-GMP™) will be available November 2021. (Photo: OrganaBio, LLC)
“Each developer has custom supply and cell needs that must be met to achieve development milestones, clinical translation, and commercialization of life-saving cell-based cures. However, the industry’s lack of a readily available and scalable supply of clinical grade starting materials has hamstrung these developers’ progress and scalability. OrganaBio meets these needs head-on by combining a proprietary supply chain of fresh tissue with in-house manufacturing capabilities. The release of cGMP and cGTP cord blood and adult peripheral blood products are examples of starting materials that can scale with a developer’s need for increased volume and donor or product characterization,“ said Justin Irizarry, CEO of OrganaBio.
Donor recruitment and tissue collections are conducted by OrganaBio’s wholly-owned subsidiaries, GaiaGift, LLC and HemaCenter, LLC. OrganaBio’s diverse donor pool consists of carefully screened individuals who undergo testing and characterization, including infectious disease testing and health and hematology assessments. HLA typing and demographic information is provided to inform donor selection and suitability of a donor’s materials for therapeutics development. Various additional donor characterization and testing options are offered to meet customer specifications and allow developers to only pay for the testing that they require.
“The regenerative medicine industry realizes that the use of cGMP-compliant materials is critical to long-term regulatory success of a program, and OrganaBio prides itself on being a good partner in addressing today’s and tomorrow’s challenges alongside our customers and partners. We are active in conversations across the industry, with companies looking to move aggressively to First-in-Human clinical trials, as well as those seeking sourcing and manufacturing solutions for later stage clinical trials and commercial scale manufacturing,” said Dr. Priya Baraniak, Vice President of Corporate Development and Head of Process and Product Development.
The launch of cGMP-compliant umbilical cord blood and adult peripheral blood products will enable the rapid deployment of additional cGMP products that the industry desires and needs. “The addition of cGMP-compliant products to OrganaBio’s portfolio of perinatal tissue- and adult blood-derived cell products and media systems will allow us to rapidly manufacture cGMP-grade cellular products that include but are not limited to HSCs, T cells, and NK cells, once our cGMP manufacturing facility opens its doors at the end of the year,” said Dr. Elina Linetsky, Vice President of Manufacturing.
OrganaBio will begin shipping HematoPAC-GMP™ and LeukoPAC-GMP™ products in November. For additional product and ordering information, please contact Dr. Priya Baraniak (email@example.com).
OrganaBio, LLC is a privately held solutions provider for the cell therapy and immunotherapy fields. OrganaBio has a proprietary tissue supply chain of perinatal and adult tissues and offers a range of starting cellular materials from these tissues. OrganaBio manufactures off-the-shelf research grade products for allogeneic cell therapy development and is building cGMP manufacturing capabilities, with a forecasted launch in Q4 2021. OrganaBio’s state-of-the-art cGMP facility will not only be used to manufacture the company’s cellular raw materials for therapeutics development, but will also offer the industry cleanrooms and support services to rapidly manufacture clinical-grade materials. This new paradigm in cGMP manufacturing affords companies flexibility and agility, significantly reducing manufacturing costs and timelines. For more information, visit www.organabio.com and follow us on LinkedIn and twitter (@organabio).
Dr. Priya Baraniak
Vice President, Corporate Development